Disposable sensor for use in measuring an analyte in a gaseous sample

ABSTRACT

The present invention is a disposable sensor for use with a device that quantifies analytes in a gaseous sample. It comprises (i) a sensing element, (ii) a means for interfacing the disposable sensor with a gas analysis device, and (iii) a housing. When used with a device that can quantify the concentration of an analyte in a gas sample, the present invention facilitates the use of exhaled breath analysis as a clinical tool.

RELATED APPLICATIONS

This application is a continuation in part of the non-provisionalapplication filed on Dec. 30, 2002, (U.S. Ser. No. 10/334,625), which inturn claims the benefit of the provisional application filed on Jul. 23,2002 (U.S. Ser. No. 60/398,216).

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to sensors for use in measuring an analyte oranalytes in a gaseous sample.

2. General Background

Analysis of a subject's exhaled breath is a promising clinical tool,with potential application in the diagnosis and treatment of manyconditions. For instance, changes in nitric oxide (NO) concentration inexhaled breath can indicate a change in the level of inflammation in theairway of an asthmatic, indicating an increase in the likelihood of anasthmatic attack. Excessive carbon monoxide (CO) can indicate hemolyticjaundice, and high levels of hydrogen can indicate carbohydratemalabsorption. Additionally, breath analysis can be used by lawenforcement officials and others to test for the concentration ofalcohol in a subject's breath.

It would be especially desirable if patients could conduct their ownbreath analysis, at home, work, or school. If they could do so, breathanalysis could be used to manage chronic diseases such as asthma.Indeed, some of the present inventors have developed both a device (U.S.Ser. No. 10/334,625) for quantifying breath analytes, and a method formanaging asthma by monitoring NO levels (U.S. Ser. No. 10/659,408). Thedisclosures of these applications are incorporated herein by referenceas if set out in full.

A necessary part of any portable breath analysis system is the sensorthat responds in some way to the analyte in the subject's breath. For avariety of reasons, sensors that are appropriate for a portable systemare not re-usable or may require calibration or user intervention tofunction adequately. There are a variety of large laboratory-basedinstruments available, but they are generally cumbersome, expensive anddifficult to maintain. Therefore, there is a need for a true disposableor calibration-free multi-use system.

SUMMARY OF THE INVENTION

The present invention is a disposable sensor for use with a device thatquantifies analytes in a gaseous sample. It comprises (i) a sensingelement, (ii) a means for interfacing the disposable sensor with a gasanalysis device, and (iii) a housing surrounding said sensing element.The housing need not be a disposable component, but could be integratedinto the reusable portion of the system.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a disposable sensor according to anembodiment of the present invention.

FIG. 2 is an exploded perspective view of a disposable sensor accordingto an embodiment of the present invention.

FIG. 3 is a cross-sectional view of a disposable sensor according to anembodiment of the present invention, showing the sensor as it is beingattached to gas analysis device.

FIG. 4 is a close-up of the circled area on FIG. 3.

FIG. 5 depicts the sequence of assembling and packaging a disposablesensor according to an embodiment of the present invention.

FIG. 6 is an exploded perspective view of a disposable sensor accordingto an embodiment of the present invention, in which the sensor has onlya single sensing element and a single cell.

FIG. 7 is an exploded perspective view of a disposable sensor accordingto an embodiment of the present invention, in which the sensor has twosensing elements and a single cell.

FIG. 8 is a perspective view of a disposable sensing element and a gasanalysis device with a sensor housing and door according to anembodiment of the present invention.

FIGS. 9 a-9 c depict the operation of a non-reuse tab in a disposablesensor according to an embodiment of the present invention.

FIG. 10 depicts a disposable sensor with interface means according to anembodiment of the present invention being installed into a gas analysisdevice.

FIG. 11 is a close up of the sensor and sensor recess as depicted inFIG. 10.

FIG. 12 is a perspective view of a sensor with diffusion ports, with itshousing cover removed, according to an embodiment of the presentinvention.

FIG. 13 depicts a sensor with electrical pads, according to anembodiment of the present invention, as it is being installed into thehousing recess of a gas analysis device.

FIG. 14 is a close-up cross section of the sensing element, electricalpads, and electrical pins of the sensor and gas analysis device shown inFIG. 13.

DETAILED DESCRIPTION

The present invention is a disposable sensor comprising a sensingelement 10, a means for interfacing 20 the disposable sensor with a gasanalysis device, and a housing 30.

The sensing element 10 responds in some quantifiable way to theconcentration of an analyte or analytes in the gaseous sample. Forinstance, in one embodiment, the sensing element is a sol-gel matrixthat encapsulates cytochrome-c, which reacts with gaseous NO to producean optically quantifiable change in the sensing element. Such a sensingelement is described in more detail in U.S. Ser. No. 10/334,625. Otherpotential sensing elements for analysis of NO include other bioactivematerials encapsulated within a sol-gel, such as hemoglobin(3+ or 2+ orO₂), myoglobin(3+, 2+ or O₂), other heme-binding proteins, porphyringroup-containing proteins, heme group-containing proteins, dye-labeledporphyrin group-containing proteins, dye-labeled heme group-containingproteins, and fragments thereof. These materials could be configured torespond in an optically quantifiable manner, or could be configured torespond by a different transduction mechanism, such as electricalimpedance or surface acoustic waves. Other suitable sensing materialsinclude organics, inorganics or synthetics that would respond to theanalyte in a quantifiable manner.

Many other sensing methods could be used to detect clinically relevantanalytes that are present in exhaled breath. These include electrical(impedance, conductance, or resistive)), chemical (electrochemical,spectrophotometric including absorbance, transmission, scattering,reflectance and fluorescence) and acoustic (surface acoustic wave). Forexample, electrochemistry could be use to detect a wide variety ofrelevant analytes including hydrogen, nitric oxide, carbon monoxide,provided that the electrochemical sensing element could be inexpensiveenough to be practical for a disposable sensor, and also provided thatthe clinically-required measurement specifications could be met. Thedisposable sensor could be configured to detect one or more analytes inthe exhaled breath. Whenever this patent refers to measurement oranalysis of an analyte, such a reference also includes measurement oranalysis of more than one analyte.

The sensing element 10 typically has at least two parts: one or moresensing materials (such as cytochrome-c), and a substrate (such as asol-gel matrix). The sensing material is the molecule that reacts orresponds in a quantifiable way to the gas sample or gas sample in thehousing 30 surrounding it. The substrate is the carrier or base for thesensing element. It might be (i) a liquid that can hold the bioactivesensing compound in suspension, emulsion or dissolved, or (ii) a polymeror glass that immobilizes the sensing compound. Suitable immobilizationagents include sol-gels, sol-gel hybrids (ormosils), Polyvinyl alcohol,Polymethylmethacrylate, polydimethylsiloxane, glass, or relatedcompounds. Any polymer or immobilization agent that allows reaction ofthe sensing compound with the gas can be used.

As noted above, the sensing element 10 responds in a quantifiable way tothe analyte or analytes of interest. Thus, in the embodiment describedabove, when the cytochrome-c complex adds a NO adduct, its spectral peakred-shifts in the blue region of the spectrum, and this change can bedetected. For purposes of this patent, optically-quantifiablecharacteristics include but are not limited to color, absorption,transmission, reflectance, scattering, luminescence, fluorescence, orphosphorescence.

The disposable sensor has an interface means 20 for interfacing with anappropriate gas analysis device, such as the device described in U.S.Ser. No. 10/334,625. See FIGS. 10 and 11. This interface means 20ensures that the sensor is properly aligned and installed into thedevice. This means 20 could take the form of a slot or recess 96 in thedevice, and the sensor would be shaped appropriately to fit into theslot 96. See FIGS. 10 and 11. The slot 96 would be configured to allowalignment of the transparent portion 64 a, 64 b, 66 a, 66 b of thesensor housing 30 with the optical transducers that would be used tomeasure the change in the optical characteristics of the sensor. SeeFIGS. 10 and 11. The slot and the sensor could be configured into ashape that would prevent incorrect insertion of the sensor such as an“L” shape or a triangle, or the shape depicted in FIGS. 10 and 11. Theslot and sensor could have a detent and tab combination positioned suchthat the sensor is locked into place when it is correctly positionedwithin the device. Alternatively the gas analysis device could have ahinged or sliding door 70 that would secure and position the sensor inplace when closed. See FIGS. 8, 10 and 11. The sensor may also havealignment aids to ensure that the sensor is properly installed. Thesealignment aids may take the form of locating pins and holes, guidingrails, hand stops, precise pockets etc., and these aids may be in eitherthe device or the sensor. Alternatively, a bayonet structure, a screw-onstructure, or a peg-structure could be used to secure the sensor to thegas analysis device, so that the optical components are properlyaligned.

The sensing element 10 could be mounted on a sensing element holder 36within the housing 30, and the housing 30 creates at least one chamberor cell 32 to contain the gaseous sample. See FIGS. 2, 3, 4, 6, 7, 8,and 12. The housing 30 also protects the sensing element, from the timethat it is manufactured until the time that is used, from exposure tothe analyte or other gasses that may interfere with its performance. Inone embodiment the housing will have a transparent portion (window) 64a, 64 b, 66 a, 66 b to facilitate detection of the optical changes tothe sensing element 10. If the sensor uses a different transductionmechanism, the housing would have the appropriate detector interfacemechanism for that transduction mechanism. For example, if the sensingelement were electrochemical, the sensor may have electrical leads orpads 80 that would allow the analyzer to measure the current or chargeproduced by the sensor. See FIGS. 13 and 14. These leads or pad wouldcontact electrical pins or electrodes 100 in the gas analysis device 90.See FIGS. 13 and 14. Electrical contact would be made when the housing30 is correctly placed within the housing recess 98 of the gas analysisdevice 90. See FIGS. 13 and 14.

The housing 30 will also have an inlet port or ports 38, 40 for entry ofthe gaseous sample and an outlet port or ports 46, 48 for exit of thegas. See FIGS. 2, 3, 6, 7, 9 a-9 c, and 12. If necessary to protect thesensing elements from ambient gasses, these ports could have protectivecovers 42, 44, 50, 52 that would be punctured, removed or otherwiseopened when the sensor was ready to perform a measurement. See FIGS. 2,3, 6, 7, 9 a-9 c, and 12. The inlet and outlet tubes 92, 94 of thedevice would be inserted into the ports to allow the device to flow agaseous sample through the sensor housing, and if the ports hadprotective covers these tubes could be made from stainless steel and besharpened to facilitate puncturing of the covers. See FIG. 3. Theprotective cover could be made of a relatively impermeable membrane suchas polymer-foil laminate material or polymer film to prevent thediffusion of interfering gasses into the housing. If protection from theenvironment was not required to maintain the performance of the sensorthe housing could be substantially built into the analyzer rather thanpart of the disposable. See FIG. 8. The housing 30 may also have a cover62 that in conjunction with sealed inlet and outlet ports seals andprotects the sensor and creates an enclosed, controllable environmentwithin the gas cell or cells. See FIG. 2. In another embodiment, it isalso possible to have a protective seal in place of the housing coverthat is removed prior to insertion if the change in the sensor housingdue to a change in environment is slow enough not to cause interferencewith the measurement. The sensor also may have means for sealing theports 38, 40, 46, 48 after opening so that the sensor is ready for use.

The housing 30 will typically be small, but obviously it must be largeenough to hold the sensing element 10, and should be sized so that itcan be easily inserted into the gas analysis device 90. In oneembodiment, where the exhaled gas is trapped in the housing for themeasurement, the sensor housing 30 must be large enough to hold asufficient quantity of exhaled gas so that the concentration of theanalyte does not decrease appreciably during the measurement process. Ifthe volume is too small the sensing element 10 could use a significantportion of the analyte reducing the amplitude of the sensing element'sresponse and, in turn, reducing the sensitivity of device. For a sol-gelencapsulated cytochrome-c based NO analyzer with approximately 25 to 50uL of a 0.03 mM cytochrome-c solution, the volume of the measurementsample inside the housing should be larger than approximately 3milliliters. If the exhaled gas is allowed to flow past the sensingelement 10 during the measurement procedure, then the size of thehousing 30 is not limited in this fashion. All or part of the housingneed not be disposable and the inlet and outlet ports can attach to thedisposable or non-disposable parts of the housing.

The housing 30 could be made of many different materials, such aspolycarbonate, acrylic, fluorocarbon polymer, polypropylene,polystyrene, glass, or metal and should be inert to the analyte that isbeing measured. To reduce the likelihood that fingerprint smudges willimpair optical analysis, the transparent portions of the housing(windows) 64 a, 64 b, 66 a, 66 b could be placed within recesses 68, 69,thereby placing the windows out of the reach of the user's fingers.Other protective embodiments include a window lining that is removableprior to insertion or is self-removed upon insertion, covering thewindow with ribs/mesh or building up the wall around the windows toprevent smudges or other optical interferences.

The sensor may also have a use limitation means 82 for ensuring that itis not re-used more than a certain number of times, or after removalfrom the gas analysis device, or after an expiration date. See FIGS. 2,9 a-9 c. There are several different mechanisms that could serve as ause limitation means 82. For instance, the use limitation means 82 couldbe an information storage device containing a code, such as anintegrated circuit (such as an EEPROM or RF tag) or a magnetic strip orbar code. The gas analysis device could read that code, and prevent ordiscourage re-use after the code has been used a certain number of times(such as once, or 30 times). Or the code could indicate an expirationdate, and the gas analysis device could prevent or discourage use of anysensor installed after its installation date. The use limitation means82 could also be mechanical or electrical, such as a tab 72 that issensed mechanically prior to use and then broken or perforated duringthe measurement process. See FIGS. 9 a-9 c. Or the use limitation means82 could be a single-use electrical fuse that is burned during use, or amechanism that senses the force required to puncture the inlet or outletprotective covers of the housing, or a system that interfaces witheither the inlet or outlet ports and then draws and measures a vacuum orpressure leaks inside the housing, thereby identifying sensors that havebeen already used once. Finally, the use limitations means 82 couldinclude a device for obtaining a spectral measurement to monitor abaseline level that is consistent with a reaction with nitric oxide.

Another feature of the present invention is the ability to providepre-calibrated disposable sensors to the user, thereby eliminating therequirement that the analyzer be periodically calibrated by the user.This provides a significant advantage to the user because calibrationtypically requires a cumbersome and difficult procedure wherebycertified gases are injected into the device in order to determinecalibration coefficients that are used in the calculation of the analyteconcentration during a test. With disposable sensors the calibrationcoefficients can be determined at the factory for each sensor. Dependingon the repeatability of the manufacturing process, calibrationcoefficients could be determined for a batch of sensors or, ifnecessary, for each individual sensor. The calibration coefficients orcode corresponding to a look-up table could then be printed on thesensor packaging so that they can be entered into the analyzer and usedfor the calculation of the analyte concentration. There are manyalternative methods to get the correct calibration coefficients into theanalyzer: A batch of sensors could be provided with a calibration codethat, when entered into the device, could be used as an index in alookup table to find the appropriate coefficients. The calibrationcoefficients could be stored in an EEPROM, RF tag or magnetic strip inthe sensor that could be read by the gas analysis device 90 prior touse. See FIG. 2. The sensor could have a calibration resistor orcapacitor (or combination) whose value or values would be read by thegas analysis device 90 and used to calculate or look up thecoefficients. The analyzer could read a bar code printed on the sensorand use that code to look up coefficients. Or the sensor could have anoptical code such as a precise aperture that is read by the analyzer andthen converted to calibration coefficient. It is also possible that thedevice will take an initial measurement of the sensor prior to breathintroduction and this will be used to calibrate the device. For purposesof this patent, “calibration information” 84 includes but is not limitedto any of the foregoing methods of providing calibration data to the gasanalysis device 90 or user. See FIGS. 1, 2.

Sample Conditioning

Depending on the precise nature of the sensing element, the sensorhousing could contain a sample conditioning unit or units 54, 56 thatfilter out unwanted substances from the exhaled breath or other gaseoussample. See FIGS. 2, 3. These sample conditioning units could fit intothe sample conditioning unit recesses 58, 60 in the housing 30. SeeFIGS. 2, 3, 6, 7, 12. For example, if the sensor element 10 responds toor is damaged by the moisture present in the breath, the sensor housingcould contain a desiccant such as zeolite to remove water vapor from thesample. Other “gettering” or filtering materials could be used to removeinterferents from the sample stream. For example, activated charcoal orsilica gels could be used to remove alcohols or other polar molecules,potassium permanganate in combination with charcoal could be used toremove NO and other oxides of nitrogen and zeolites could be used toremove a variety of gasses based on their molecular size. The sampleconditioning units 54, 56 could also be used to maintain a storageenvironment for the sensing element. If, for example, the sensingelement required a certain concentration of water vapor to be presentfor it either to function correctly or to maintain its activity over itsshelf life, the sample conditioning units 54, 56 could include “artsorb” (a material designed to maintain a fixed humidity over a widerange of environmental conditions), a saturated salt solution thatmaintains a fixed humidity, or a desiccant to remove water vapor fromthe interior of the housing. If equilibration with the environment isrequired, Nafion, or equivalent, tubing could be incorporated into thedevice to equilibrate with room humidity and temperature. When separatesensing elements are used to measure different analytes, differentsample conditioning units 54, 56 could be used for each analyte.

Differential Measurement

The sensor may also have a system or systems for ensuring that theintegrity of the measurement is not compromised by “noise” or otherextraneous signals. A common approach to reducing the amount of noise ina measurement is to take a differential measurement. In its simplestimplementation this technique requires two channels, one that respondsto both the measurement of interest and the noise or interference andone channel that responds primarily to the source of noise. In other,more complicated implementations the signal of interest is reconstructedvia a mathematical manipulation of two or more channels. For example, ifthe two channels respond to the noise in a similar manner but thereference channel has a different gain, the reference channel could bescaled prior to subtraction to better cancel the noise signal. Thisconcept can be extrapolated such that one or both of the channels can bemathematically transformed by linear, nonlinear, time dependent and timevarying functions to remove noise from the measurement. There are manycommon accepted mathematical techniques to determine the transformationrequired to separate signal from the noise.

Many techniques can be used to create a two-channel system, with onechannel that is responsive to noise and the concentration of the analyteand a separate channel that is primarily responsive to only noise. Inthe simplest embodiment, one channel could contain the sensing elementin its path while the second channel does not. In this configuration thechannel without the sensing element would respond to noise caused byvariations in the light output or changes in ambient conditions whilethe channel with the sensing element would respond to the same “commonmode” noise as well as the changes caused by the analyte. In order toextract the signal of interest from the noise either the ratio of thetwo signals could be measured or the signals could be scaledappropriately and then subtracted.

If there are additional sources of noise, beyond the noise due tovariations of the light intensity reaching the sensing element, morecomplex differential measurement schemes could be implemented. Forexample, two sensing elements 10, 12 could be used, one in each of thecells 32, 34, or both in the same cell 32, where one element has beentreated so that it does not respond to the analyte but does respond toother interfering signals. See FIGS. 2 and 7. Examples of such treatmentinclude chemically, thermally, electrically or photonically denaturingthe sensing material, coating the sensing element with a material thatis not permeable to the analyte such as Nafion, removing the cytochromec from the sensing element, modifying the cytochrome-c structure to makeit unresponsive to the analyte or using a sensing material that respondssimilarly to interferents (such as a porphyrin ring or similar protein)but not to the analyte. Alternatively, two similar sensing elementscould be used, but the gas sample could be split into two separate gascells 32, 34, where the analyte is selectively removed from one cell sothat both channels respond to potential interfering gases in addition toother noise sources (like light intensity variations) while one channelresponds to the analyte as well. Nitric oxide could be removed by usinga potassium permanganate filter to react the NO to produce NOx andcharcoal to remove the NOx, or a zeolite could be used to trap the NO.In this configuration one gas cell may have a sample conditioning unit54 or both cells may have different sample conditioners.

Diffusion Port

Since many of the proposed sensor elements require a chemical reactionto take place to sense the analyte, and since chemical reactions areinherently temperature sensitive, it may be advantageous to have adiffusion port or ports 76, 78 between the sensing element and theexhaled gas sample in order to limit the rate of reaction to a knownvalue. The diffusion characteristics of the analyte, while temperaturedependent, can be significantly less sensitive to temperature than therate of the chemical reaction. Therefore the diffusion port willdecrease the sensitivity of the analyzer to temperature variations. Adiffusion port will also make the device less sensitive to other factorsthat affect the rate of reaction such as process variables, formulationvariations, changes in substrate and others. In effect the diffusionport would act as a well controlled “rate limiting step” in thetransduction mechanism reducing the variability in the performance ofthe device. The diffusion ports 76, 78 can take the form apertures in asensing element barrier 74 which shields the sensing element 12 from thebulk of the sample inside the gas cell 32, 34, as shown in FIG. 12.

Packaging

Certain types of sensing elements need to be stored in preciselycontrolled environments to maintain their sensitivity to the analyte atthe desired level during storage. For example cytochrome-c encapsulatedin a sol gel matrix has different sensitivity to NO depending on thelevel of ambient water vapor present. For this type of sensor it isdesirable to store the sensor at a fixed water vapor concentration sothat sensitivity to NO is well characterized when the sensor is used.The water vapor concentration may also play a role in maintaining thesensitivity of the sensor over time and could be important indetermining the shelf-life of the sensor. It might also be necessary toprotect the sensor from the ambient levels of the analyte. In order tomaintain this specific environment, as could be done inside the housingusing the sample conditioning units, a storage compound 112, such as adesiccant and/or a saturated salt solution may need to be placed in thestorage pouch 110 for the sensor. See FIG. 5. The storage compound(desiccants and/or salt solutions) may need to be stored with eachindividual sensor or with groups of sensors in their primary packaging110, particularly if the pouch is re-sealable. The primary packaging canthen be in the secondary packaging 120. See FIG. 5

Depending on the use, the sensing element will need to have certainperformance characteristics. For instance, in the embodiment in whichcytochrome-c in a sol-gel is used to measure NO for managing asthma, thesensing element may have a measurement range of 0-200 ppb, with aminimum detection limit of 5 ppb, and a resolution of 2.5 ppb.

In operation, the user would insert the disposable sensor into thedevice, and then use a breath-sampling system to transport the breath tothe sensor housing. Breath analysis would then occur one or more times,and afterwards, the user would remove and dispose of the sensor. Thesensor may be used to perform more than one measurement. Subsequently,upon next use, the user would install a new sensor. No tools wouldtypically be required to install or remove the disposable sensor.

The sensor of the present invention is disposable, but that does notmean that it must necessarily be disposed of after a single use.Instead, for purposes of the present patent, “disposable” merely denotesthat the sensor should not be used more than thirty times, and that itshould not be re-used after removal from the device.

One skilled in the art will appreciate that the present invention can bepracticed by other than the preferred embodiments, which are presentedfor purposes of illustration and not of limitation.

1.) A method of measuring the concentration of an analyte in a gassample of exhaled breath, comprising: providing a first disposablesensor, said first sensor comprising a sensing element, wherein saidsensing element undergoes a change in the presence of said analyte;loading said first sensor into a gas analysis device; measuring theconcentration of said analyte in an exhaled breath sample using saidfirst disposable sensor and said gas analysis device; removing saidfirst sensor from said device; and installing a second disposable sensorinto said device. 2.) The method according to claim 1, wherein saiddisposable sensor is within a disposable housing. 3.) The methodaccording to claim 1, wherein said change is a change in an opticallyquantifiable characteristic. 4.) The method according to claim 1,wherein said analyte is nitric oxide. 5.) The method according to claim4, wherein said sensing element comprises a sol-gel. 6.) The methodaccording to claim 5, wherein said sensing element additionallycomprises cytochrome-c. 7.) The method according to claim 1, wherein thestep of measuring the concentration of an analyte in a gas sample usingsaid disposable sensor and said gas analysis device comprises employingmeans for ensuring that extraneous signals do not interfere withmeasurement. 8.) The method according to claim 7, wherein said means forensuring that extraneous signals do not interfere with measurementcomprises two separate channels for analysis of the gas, wherein one ofsaid channels is used for reference analysis. 9.) The method accordingto claim 7, wherein said means for ensuring that extraneous signals donot interfere with measurement comprises using two separate sensingelements for analysis of the gas, wherein one of said elements is usedfor reference analysis. 10.) The method according to claim 1,additionally comprising conditioning the gas sample before measurement.11.) The method according to claim 1, wherein said first disposablesensor uses calibration information associated with said sensor. 12.) Adisposable sensor for use with a device that quantifies theconcentration of an analyte in a gaseous sample of exhaled breath,comprising: a disposable sensing element, wherein said disposablesensing element is responsive to the analyte; and means for installingsaid disposable sensor into said device. 13.) The sensor according toclaim 12, additionally comprising a disposable housing surrounding saiddisposable sensing element. 14.) The sensor according to claim 12,wherein said sensing element is optically responsive to the analyte.15.) The sensor according to claim 12, wherein said analyte is nitricoxide. 16.) The sensor according to claim 15, wherein said sensingelement comprises a sol-gel. 17.) The sensor according to claim 16,wherein said sensing element additionally comprises cytochrome-c. 18.) Adisposable sensor for use with a device that quantifies theconcentration of an analyte in a gaseous sample of exhaled breath,comprising: a sensing element; and an interface means for interfacingsaid sensor with said device. 19.) The sensor according to claim 18,wherein said interface means comprises a means to align an opticalwindow in said sensor with an appropriate location or locations on saiddevice. 20.) The sensor according to claim 18, wherein said interfacemeans comprises a means to align electrical contacts associated withsaid sensor with an appropriate location or locations on said device.21.) The sensor according to claim 18, wherein said interface meanscomprises a slot in said device and a guide in said sensor. 22.) A kitfor analyzing the concentration of an analyte in a sample of exhaledbreath, comprising: a plurality of disposable sensors, wherein saidsensors include a disposable sensing element responsive to said analyte;a gas analysis device for use with said sensors, comprising means formeasuring the concentration of said analyte in said exhaled breath. 23.)The kit according to claim 22, wherein said sensor additionallycomprises a disposable housing surrounding said disposable sensingelement. 24.) The kit according to claim 22, wherein said sensingelement is optically responsive to the analyte. 25.) The kit accordingto claim 22, wherein said analyte is nitric oxide. 26.) The kitaccording to claim 25, wherein said sensing element comprises a sol-gel.27.) The kit according to claim 26, wherein said sensing elementadditionally comprises cytochrome-c. 28.) A sensor for use with a devicethat quantifies the concentration of an analyte in a gaseous sample ofexhaled breath, comprising: a sensing element; and a use limitationmeans. 29.) The sensor according to claim 28, wherein said uselimitations means comprises a means for preventing or discouraging useof the sensor after it has been used a certain number of times. 30.) Thesensor according to claim 29, wherein said certain number of times isthirty. 31.) The sensor according to claim 29, wherein said certainnumber of times is one. 32.) The sensor according to claim 28, whereinsaid use limitations means comprises a means for preventing ordiscouraging use of the sensor after an expiration date. 33.) The sensoraccording to claim 28 or 32, wherein said use limitations meanscomprises an information storage device. 34.) The sensor according toclaim 33, wherein said information storage device comprises anintegrated circuit. 35.) The sensor according to claim 33, wherein saidinformation storage device comprises a magnetic strip. 36.) The sensoraccording to claim 28, wherein said use limitation means comprises ameans for preventing or discouraging use of the sensor after it has oncebeen removed from a gas analysis device. 37.) The sensor according toclaim 36, wherein said use limitations means comprises a tab. 38.) Thesensor according to claim 36, wherein said use limitations meanscomprises a fuse. 39.) The sensor according to claim 36, wherein saiduse limitations means comprises a means for detecting a leak within saidsensor. 40.) A disposable sensor for quantifying the concentration of ananalyte in a gaseous sample of exhaled breath, comprising: a housing; adisposable sensing element within said housing; and a port in saidhousing for entry of said gaseous sample of exhaled breath; and meansfor sealing said port until it is time for the sensor to receive the gassample of exhaled breath. 41.) The sensor according to claim 40, whereinsaid means for sealing said port is a puncturable cover. 42.) The sensoraccording to claim 40, additionally comprising: a second port in saidhousing for exit of said gaseous sample of exhaled breath; and means forsealing said second port until it is time for the sensor to receive agas sample of exhaled breath. 43.) The sensor according to claim 42,wherein said means for sealing said second port is a second puncturablecover. 44.) A sensor for use with a device that quantifies theconcentration of an analyte in a gaseous sample of exhaled breath,comprising: a housing; a disposable first sensing element within saidhousing; and means for accounting for the effect of interfering signalsthat might otherwise impede accurate calculation of said concentration.45.) The sensor according to claim 44, wherein said means for means foraccounting for the effect of interfering signals comprises two gas cellswithin said housing. 46.) The sensor according to claim 44 or 45,wherein said means for means for accounting for the effect ofinterfering signals comprises a second sensing element within saidhousing. 47.) A sensor for use with a device that quantifies theconcentration of an analyte in a gaseous sample of exhaled breath,comprising: a housing; a disposable sensing element within said housing;and a first sample conditioning unit within said housing. 48.) Thesensor according to claim 47, wherein said sample conditioning unitcomprises zeolite (5A or 13x), a silica gel, or another desiccant. 49.)The sensor according to claim 47, wherein said sample conditioningcomprises potassium permanganate combined with charcoal or zeolite 3A.50.) The sensor according to claim 47, additionally comprising a secondsample conditioning unit, wherein said first sample conditioning unit isfor use in measuring a first analyte, and said second sampleconditioning unit is for use in measuring a second analyte. 51.) Asensor for use with a device that quantifies the concentration of ananalyte in a gaseous sample of exhaled breath, comprising: a housing; adisposable sensing element within said housing; and a means for limitingthe rate of diffusion of said sample. 52.) The sensor according to claim51, wherein said means for limiting the rate of diffusion comprises adiffusion port. 53.) A disposable sensor for use with a device thatquantifies the concentration of an analyte in a gaseous sample ofexhaled breath, comprising: a disposable sensing element; andcalibration information associated with said sensing element. 54.) Thesensor according to claim 53, wherein said calibration informationcomprises text for reading by a user. 55.) The sensor according to claim54, wherein said text comprises a code. 56.) The sensor according toclaim 54, wherein said text comprises a coefficient table. 57.) Thedisposable sensor according to claim 53, wherein said calibrationinformation is stored in an integrated circuit associated with saidsensing element. 58.) The disposable sensor according to claim 53,wherein said calibration information is stored in a bar code associatedwith said sensing element. 59.) The disposable sensor according to claim53, wherein said calibration information is stored in an optical codeassociated with said sensing element. 60.) A package of disposablesensors, comprising: a plurality of disposable sensors for use inanalyzing exhaled breath; and a storage compound placed near saidsensors. 61.) The package according to claim 60, wherein said storagecompound comprises a desiccant. 62.) The package according to claim 60,wherein said storage compound comprises a salt solution. 63.) A systemfor analysis of a gaseous sample, comprising: a device for the analysisof exhaled breath; a plurality of disposable sensors, said sensorsinstallable in said device. 64.) A sensor for use with a device thatquantifies the concentration of an analyte in a gaseous sample ofexhaled breath, comprising: a housing with a transparent window; adisposable sensing element within said housing; and means for protectingsaid window from smudges or other optical interferents. 65.) The sensoraccording to claim 64, wherein said means for protecting said windowcomprises placing said window in a recess in said housing. 66.) Thesensor according to claim 64, wherein said means for protecting saidwindow comprises a protective covering over said window.